PHPT-5 first phase

The purpose of this study is to compare the efficacy, long term safety for infants and mothers, and feasibility of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose nevirapine given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis for the prevention of mother-to-child transmission of HIV.

The study represents a collaborative effort of Harvard University, the IRD (France), the Thai Ministry of Public Health, and Mahidol and Chiang Mai Universities, through a network of 21 public hospitals in Thailand. If the simple ZDV+LPV/r28w regimen proves to be efficacious and safe for PMTCT, avoiding risks of resistance mutations to NNRTIs for both mothers and infected children, this study will have important public health implications for industrialized and developing countries.